The overall study objective is to evaluate Chondrofix Osteochondral Allograft ("Chondrofix") for the repair of osteochondral lesions in the knee. This includes, but is not limited to primary cartilage lesion repair and revision of failed prior cartilage repair treatments. The study hypothesis is that Chondrofix Allograft will provide pain relief and functional improvement as demonstrated by a comparative analysis of baseline clinical evaluations at 24 months of follow-up.
Knee cartilage injuries are a major cause of pain and functional impairment in young to middle age adults and can lead to progressive joint degeneration. In response to challenges with current cartilage repair options, Chondrofix Allograft was developed as an off-the-shelf treatment option adding to the variety of cartilage reparation offerings. This study is a multicenter, prospective, post-market clinical outcomes study designed to assess the clinical outcomes of Chondrofix Allograft used in the treatment of both primary and revision cartilage repair cases. Study design includes up to 6 qualified investigational sites with 50 subjects enrolled across all centers during an 18 month enrollment period. Study subjects will be followed postoperatively for 5 years. The Investigators who are responsible for the conduct of this study in compliance with this protocol will be orthopedic surgeons who are skilled in the techniques of articular cartilage repair.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Allogeneic, cylindrical, decellularized, osteochondral graft composed of hyaline cartilage and bone
Plancher Orthopaedics and Sports Medicine
Cos Cob, Connecticut, United States
The Orthopaedic Group, LLC
New Haven, Connecticut, United States
Orthopaedic Research Foundation, Inc.
Greenwood, Indiana, United States
Cartilage Repair Center, Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
Specialized Orthopaedics and Sports Medicine
Columbus, Ohio, United States
KOOS Subscale
The overall mean change from baseline to 24 months in the KOOS Pain and KOOS Function in Daily Living (ADL) subscale scores.
Time frame: 24 Months
X-ray & MRI Evaluation
Time frame: Baseline and 1.5, 3, 6, 12, 24, & 60 months
IKDC Knee Examination
Time frame: Baseline & 1.5, 3, 6, 12, 24, & 60 months
Subject Reported Questionnaires
Time frame: Baseline and 1.5, 3, 6, 12, 24, 36, 48, and 60 months
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